Kornimate/medical-research-clean huggingface dataset:
dose-ranging study to evaluate the effectiveness and tolerability of mk0736 in patients with type 2 diabetes mellitus (t2dm) and hypertension (0736-007)

Conditions: Type 2 Diabetes Mellitus; Hypertension

Summary: the study will assess the efficacy and tolerability of mk0736 in patients with type 2 diabetes mellitus and hypertension who are on ongoing therapy with angiotensin-converting enzyme or angiotensin receptor blocker. after a 3 to 5 week pre-randomization phase, patients will be randomized to either mk0736 (3 doses), placebo, or hydrochlorothiazide (hctz). the study will also include a 3 week, posttreatment follow-up period.


Eligibility criteria:
inclusion criteria: * must be 18 to 75 years of age * type 2 diabetes mellitus (glycohemoglobin \[a1chba1c\]: 7 to 10%) * hypertension: diastolic blood pressure (dbp; 85 to 99 mm hg) and systolic blood pressure (sbp; 120 to 159 mm hg) * ldl-c \< 140 mg/dl * on stable treatment with an angiotensin-converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) exclusion criteria: * history of type i diabetes mellitus or ketoacidosis * patients taking 3 or more blood pressure lowering medications * have severe chronic heart failure * history of certain diseases or conditions such as cardiac arrhythmias, heart attack, stroke, unstable angina, or decompensated vascular disease * history of cancer within the last 5 years * human immunodeficiency virus (hiv) positive * have received treatment with any investigational drugs within the past 30 days * history of alcohol or drug abuse within the past 3 years * body mass index ( bmi) \>= 41 kg/m2
remote eeg device for identification of risk for neonatal seizures

Conditions: Neonatal Encephalopathy

Summary: the purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.

our goals are to evaluate the effectiveness of the epilog device in identification of neonates who are at risk for seizures and need formal eeg monitoring or cooling. the current process for these patients would be transfer from rochester methodist hospital to the st. mary's level 3 nicu for eeg monitoring. given that in case of neonatal encephalopathy, there is 6-hour window in which to make the critical decision of whether to initiate therapeutic hypothermia or not, rapid access to eeg data is crucial. we would like to perform a pilot study on use of wireless eeg technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp eeg.

Eligibility criteria:
inclusion criteria: * age 28 days old or less (postnatal age) * neonatal encephalopathy as judged by clinical team or symptoms concerning for subtle seizures * patient currently in level 1 newborn nursery or level 2 or 3 nicu exclusion criteria: * medical comorbidity which would result in prolonged need for sedation * prolonged eeg monitoring is medically indicated
the evaluation of the safety and effectiveness of animers chiara la and juvéderm voluma® for aging mid-face

Conditions: Dermal Filler; Hyaluronic Acid; Lidocaine; Aging Mid-Face

Summary: this study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the active control group.


Eligibility criteria:
inclusion criteria: 1. age 30 to 60 years of male or female 2. midface volume deficit scale (mfvds) of midface graded 2 to 5 by evaluator. exclusion criteria: 1. injection site with infection or other skin diseases present which may affect the evaluation 2. with medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at midface 3. with permanent implants or planning to receive permanent implants during the study period at the injection sites 4. hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 6 months 5. with under-eye facial botox or fat injection within the past 6 months or planning to receive under-eye facial botox or fat injection during the study period 6. with major surgery 3 months before the start of the trial 7. with under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period 8. with systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.) 9. with clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications 10. with epilepsy or porphyria 11. with congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency 12. with analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period 13. with history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; gram-positive bacterial or streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study 14. planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change 15. pregnant, planning pregnancy or in breastfeeding females 16. participated in clinical study of other device or drug and have not terminated within the past 30 days -other circumstances which judged to be unsuitable for participating in the study by the investigator
effect of vitamin a in the treatment of neonatal sepsis and necrotizing enterocolitis

Conditions: Sepsis; Necrotizing Enterocolitis; Meningitis; Pneumonia

Summary: the purpose of the study is to determine whether vitamin a can improve survival and facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.

sepsis and necrotizing enterocolitis (nec) are leading causes of morbidity and mortality in neonates. studies have shown that early reversal of the signs associated with severe disease is an important prognostic factor during acute illness. vitamin a deficiency is widespread among children, including neonates, in developing countries. vitamin a plays an important role in mediating immune responses and in maintaining epithelial integrity. for this reason vitamin a supplementation during the acute phase of neonatal infection could work synergistically with present antibiotic regimens in promoting early reversal of signs associated with adverse outcome and shorten the total duration of clinical illness. the purpose of the proposed hospital-based clinical trial is to evaluate the efficacy of vitamin a supplementation on reducing the morbidity and mortality among neonates hospitalized with sepsis (n=366) and nec(n=150). enrolled subjects will be randomized at the time of hospitalization to receive one dose of either 50,000 iu of vitamin a or placebo at enrollment, in addition to standard antibiotic therapy. we will compare the proportion of treatment failures in sepsis patients, the frequency of disease progression and mortality in nec patients, and the time to clinical recovery and discharge between treatment groups. in addition, the study will determine whether vitamin a reduces pro-inflammatory cytokine levels; elevated host inflammatory cytokines are thought to contribute to the severity of both conditions. if vitamin a is found to be efficacious in the treatment of sepsis and nec it could present a needed cost-effective approach to decreasing the global morbidity, mortality and the economic cost associated with neonatal sepsis and nec in the developing world.

Eligibility criteria:
inclusion criteria: * newborns less than 29 days with clinical sepsis exclusion criteria: * healthy infants * major congenital abnormalities * known inborn error(s) of metabolism * chronic disorders of other organs (e.g. cholestasis) * definite or severe nec (\> stage 2) * congenital heart disease * infants receiving va supplements * infants requiring mechanical ventilation * infant is unconscious

Keywords: vitamin a treatment neonates newborn sepsis necrotizing enterocolitis meningitis pneumonia
postoperative pain and ptn and reciproc

Conditions: Apical Periodontitis; Dental Pulp Necrosis

Summary: in this clinical trial, the researchers will investigate the effect of single-file reciprocating file system (reciproc) versus multi-file rotational file systems (protaper next) on the postoperative pain in adult patients who have necrotic pulp and apical periodontitis. the participants will be assigned by chance to separate groups that compare 2 different treatments, reciprocating single-file system (reciproc) and rotational multi-file system (protaper next).

the infected root canal treatments will be performed using one-visit approach with either a reciprocating single-file system or a continuous rotational multi-file system. foraminal enlargement will be perfomed using either reciproc or protaper next file systems. the root canals will be completed in single-visit. the patients will record their postoperative pain during the follow-up period using a vas scale.

Eligibility criteria:
inclusion criteria: participants who have in their mandibular or maxillary molar teeth necrotic pulp and apical periodontitis. exclusion criteria: pregnancy, drug hypersensitivity, cardiac problems, previously performed endodontics treatment.
pulse oximeter responses to multiple levels of stable hypoxia

Conditions: Hypoxia

Summary: validate pulse oximeter sensor spo2 accuracy from 70-100% during induced hypoxia.

the testing is conducted on 10 healthy, consenting, non-smoking subjects in accordance with the irb approved protocol. the subjects shall be distributed across both genders and a range of skin tones as equally as practical. an arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. the subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip. hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. inspired o2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal po2 and pco2, as sampled by a mass spectrometer. predicted levels of oxyhemoglobin saturations will be attained and held stable. at a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. after approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. the samples will immediately be analyzed by a radiometer osm-3 multi-wavelength co-oximeter and recorded. the spo2 data from the oximeters will be collected via a laptop computer. concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Eligibility criteria:
inclusion criteria: * non-smoker * 18 years or older * meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels * understand and provide signed consent for the procedure exclusion criteria: * smoker * user of illegal drugs * hypertension * respiratory disease * known allergy to lidocaine or its derivatives * those suffering from upper respiratory infection on the day of study
underlying abnormalities in fat and muscle leading to lipodystrophy syndrome

Conditions: HIV Infections; Lipodystrophy; Insulin Resistance

Summary: with the advent of highly active anti-retroviral therapy(haart), patients with hiv disease are developing a series of metabolic abnormalities including peripheral fat wasting, increase in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar) resistance with an increased incidence of type 2 diabetes mellitus and elevated blood pressure. the premise of this study is that abnormalities in the ability of fat and muscle tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high serum triglyceride levels and abnormal fat distribution. the purpose of the study is to assess how insulin resistant patients with hiv disease are and if their fat and muscle tissue are responding abnormally to insulin. this is done by administering insulin and taking small tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in these tissues. patients with hiv disease will be admitted into the study after undergoing a screening medical history and examination. once patients qualify, they will have their insulin resistance measured as well as the response of their fat and muscle to insulin; blood levels of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed using radiological tests; a detailed medical history will be obtained to assess risk factors for developing this syndrome. patients who are found to be insulin resistant will be offered a trial of an insulin sensitizing agent, called avandia, for 6-12 weeks. it is hoped that the avandia will restore the body's ability to respond normally to insulin (as it does in patients with diabetes) and perhaps improve the fat abnormalities as well. all the same measures will be performed at the end of the course of avandia as were done at baseline. patients who are not insulin resistant will be asked to come back yearly to assess whether they develop insulin resistance over time. this study will continue to recruit patients over the next 3 years.


Eligibility criteria:
inclusion criteria: * 18 years and older * diagnosis of hiv or aids exclusion criteria: * positive pregnancy test * diagnosis of cancer * acute illness (patients can be enrolled once stable) * hemoglobin less than 7.0 g/dl or acute heart problems * renal function greater than creatinine 1.5 mg/dl * liver dysfunction 3 times normal * use of medications like glucocorticoids and birth control pills * untreated hypertension * diabetes mellitus

Keywords: peripheral fat wasting truncal adiposity fat biopsy muscle biopsy intravenous lines blood draws insulin administration sugar water screening
genetics of epilepsy and related disorders

Conditions: Epilepsy; Epileptic Encephalopathy; Ohtahara Syndrome; Infantile Spasms; Dravet Syndrome; Early Myoclonic Epileptic Encephalopathy; PCDH19-related Epilepsy and Related Conditions; KCNQ2-Related Epileptic Encephalopathy; Epilepsy of Infancy With Migrating Focal Seizures (Disorder)

Summary: investigators at boston children's hospital are conducting research in order to better understand the genetic factors which may contribute to epilepsy and related disorders. these findings may help explain the broad spectrum of clinical characteristics and outcomes seen in people with epilepsy.

many individuals with epilepsy experience seizures which respond well to treatment. some types of epilepsy, however, are characterized by seizures which begin very early in childhood and are associated with severe intellectual and/or developmental disabilities. these conditions are often difficult to treat. the investigators' research effort is focused on identifying genetic changes (known as "dna variants") that cause epilepsy. by doing so the investigators hope to improve diagnosis and treatment for this epilepsy. we have two specific aims: 1. identifying genetic findings in patients with epilepsy and related disorders. 2. correlating genetic findings with epilepsy phenotypes.

Eligibility criteria:
for gene-steps: inclusion: seizure onset at less than 12 months of age, must be enrolled within 6 weeks of first seizure-related presentation to bch exclusion: simple febrile seizures, provoked seizures, genetic or acquired cause already identified, mri findings consistent with specific genetic etiology for bch crdc: inclusion: diagnosis of epilepsy, patient at bch exclusion: existing genetic diagnosis or known cause for epilepsy, structural malformation of the brain for core cohort: inclusion: diagnosis of epilepsy exclusion: existing genetic diagnosis or known cause for epilepsy, structural malformation of the brain for phenotyping cohort: inclusion: diagnosis of a genetic epilepsy exclusion: no genetic diagnosis or diagnosis of other genetic condition that does not include epilepsy phenotype

Keywords: epilepsy ohtahara dravet eiee genetic
effect of ketamine and etomidate during rsi on long term outcomes

Conditions: Post-Traumatic Stress Disorder; Acute Respiratory Failure

Summary: the rsi-lto study collects long-term outcomes from the rsi trial (nct05277896). one-third of adults who are intubated in the ed or icu experience symptoms of posttraumatic stress disorder (ptsd). ptsd is a psychiatric disorder triggered by a "shocking, scary, or dangerous event." critical illness, tracheal intubation, and mechanical ventilation can be traumatic and distressing events. patients may recall the intubation procedure, the feeling of the breathing tube in their throat, or being unable to move ("paralyzed"). while on the breathing machine, patients may experience delirium, frightening hallucinations, and delusions. patients with ptsd after critical illness can be hypervigilant, anxious, and troubled by intrusive thoughts, nightmares, and flashbacks that last months to years after critical illness and that ptsd negatively impacts patients' marriages, work, and quality of life and increases patients' risk of depression, anxiety, substance use disorder, and suicide. ketamine may prevent ptsd symptoms by blocking the pathways in the brain's glutaminergic system that are responsible for the formation of traumatic memories in outpatients with chronic ptsd, a single dose of ketamine has been shown to reduce ptsd symptoms for up to 2 weeks. even a modest reduction in ptsd would translate into tens of thousands of fewer cases of ptsd each year, more cases of ptsd each year than any other medical intervention evaluated to date.


Eligibility criteria:
inclusion criteria: * enrolled in rsi trial (nct05277896) exclusion criteria: * aphasic or non-verbal prior to tracheal intubation * cannot follow commands prior to tracheal intubation * non-english speaking * deaf
a study of low dose vs standard ticagrelor on platelet function after intervention for acute coronary syndrome in senior patients

Conditions: Senior Acute Coronary Syndrome Patients After PCI

Summary: in this study, the investigates try to confirm our hypothesis that low dose ticagrelor(60mg) had similar anti-platelets function compared with the standard dose ticagrelor in senior （no less than 75 years old)acute coronary syndrome patients . totally 40 senior acs patients will be divided into 2 groups randomly one month after pci . group 1 will be treated with ticagrelor 90mg and aspirin 100mg after pci for 12 months as the standard group; group 2 will be treated with ticagrelor 60mg plus aspirin 100 mg for 11 months after one month standard dapt treatment. the platelets function will be tested in vasp and teg methods 2 months after pci as the primary endpoints.the clinical events will be observed 12 months after pci.


Eligibility criteria:
inclusion criteria: 1.subject must be at least 75 years of age 2 patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome 3.subject understand the study requirements and the treatment procedures and provided informed consent before the procedure exclusion criteria: 1. female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study 2. active bleeding 3. known hypersensitivity or contraindication to study medications 4. female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study 5. non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment). 6. subjects with cerebral hemorrhage history 7. subjects with stroke history in half a year 8. subjects with active malignant tumor 9. subjects with whom oral anticoagulants are needed 10. other conditions which the investigators think not applicable to the study.
hypothermia in acute ischemic stroke - surface versus endovascular cooling (hais-se)

Conditions: Ischemic Stroke; Thrombolysis; Hypothermia

Summary: hais-se is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. but the prove of clinical benefit in patients with acute ischemic stroke is still missing: most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. in addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients. hais-se is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

Eligibility criteria:
inclusion criteria: * ischemic stroke * intravenous thrombolysis within 4.5h from symptom onset * informed consent of the patient * nihss score ≥ 2 and ≤ 20 * age ≥ 18 and ≤ 90 years * placement of cooling catheter / cooling pads within 6h from symptom onset exclusion criteria: * (expected) intubation (e.g. for interventional treatment) * pregnancy * body weight \> 120kg * body height \< 150cm * life-expectancy \< 3 months * fever \> 38.5°c at screening * known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia) * known vasospastic vascular disorder (e.g. raynaud's phenomenon or thromboangiitis obliterans) * possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter * acute pulmonary embolism * acute myocardial infarction * severe cardiac insufficiency (nyha ≥ iii) * threatening ventricular dysrhythmia * qtc-interval \> 450ms * bradycardia \< 50/min * sick-sinus-syndrom * av-block \> i° * severe infection with bacteremia or sepsis ≤ 72h * severe renal (gfr \< 30ml/min) or liver insufficiency (child-pugh c) * myopathy * known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine. * treatment with mao-inhibitors ≤ 14 days * acute closed-angle glaucoma

Keywords: hypothermia induction of hypothermia non invasive cooling external cooling surface cooling endovascular cooling cooling catheter stroke shivering neuro monitoring coagulation